On-X Ascending Aortic Prosthesis, Instructions For Use Manual

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On-X
®
-protese til aorta ascendens, brugsanvisninger 1
Dansk
INDHOLDSFORTEGNELSE
1. BESKRIVELSE AF ENHEDEN ............................................................ 3
2. INDIKATIONER ................................................................................ 3
3. KONTRAINDIKATIONER .................................................................. 3
4. ADVARSLER OG FORHOLDSREGLER .............................................. 4
4.1 Advarsler ...........................................................................................4
4.2 Forholdsregler...................................................................................5
5. MULIGE KOMPLIKATIONER ............................................................ 6
6. INDIVIDUEL BEHANDLING .............................................................. 7
6.1 Specifik patientpopulation ................................................................7
7. PATIENTRÅDGIVNING ..................................................................... 7
8. LEVERING ........................................................................................ 7
8.1 Tilgængelige modeller og størrelser ................................................7
8.2 Holderhåndtag til protesen til aorta ascendens ...............................7
8.3 Emballage .........................................................................................8
8.4 Opbevaring .......................................................................................8
8.5 Tilbehør .............................................................................................8
9. ANVISNINGER I BRUG..................................................................... 9
9.1 Oplæring af kirurgen ........................................................................9
9.2 Sterilisering og gensterilisering ........................................................9
9.3 Anvisninger om håndtering og klargøring .....................................11
9.4 Implantation af enheden ................................................................12
9.5 Klapsutureringsteknikker .................................................................12
9.6 Graftlængde og suturering .............................................................12
9.7 Kontrol af fligenes bevægelse og klaprotation ..............................13
9.8 Klappens orientering ......................................................................13
10. POSTOPERATIVE OPLYSNINGER ................................................. 14
10.1 MR-scanning, kompatibilitet .........................................................14
10.2 Returvarer......................................................................................15
11. PATIENTOPLYSNINGER ............................................................... 15
11.1 Patientregistrering ........................................................................15
11.2 Patientregistreringskort .................................................................15
12. ANSVARSFRASKRIVELSE ............................................................. 15